BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 22192992 · Received June 12, 2025

    Report

    Report Number
    1823260-2025-01804
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    May 21, 2025
    Report Date
    August 27, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE E801 ANALYZER SERIAL NUMBER WAS (B)(6) .

    Additional Manufacturer Narrative · 0

    THE CUSTOMER COMPLAINED OF DISCREPANT TROPONIN T HS RESULTS FOR ADDITIONAL PATIENT SAMPLES (PATIENTS 4 - 14) : ON (B)(6) 2025, PATIENT 4 INITIAL RESULT WAS 36.8 NG/L. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 31.8 NG/L AND 26.6 NG/L. PATIENT 5 INITIAL RESULT WAS 13.2 NG/L. THE SAMPLE WAS REPEATED 3 TIMES WITH RESULTS OF 9.3 NG/L, 3.5 NG/L, AND 3.4 NG/L. PATIENT 6 INITIAL RESULT WAS 37 NG/L. THE SAMPLE WAS REPEATED 3 TIMES WITH RESULTS OF 31 NG/L, 29.7 NG/L, AND 30 NG/L. ON (B)(6) 2025, PATIENT 7 INITIAL RESULT WAS 15.1 NG/L. THE SAMPLE WAS REPEATED 3 TIMES WITH RESULTS OF 11 NG/L, 10.2 NG/L, AND 9.9 NG/L. ON (B)(6) 2025, PATIENT 8 INITIAL RESULT WAS 33.9 NG/L. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 27.6 NG/L AND 25.8 NG/L. PATIENT 9 INITIAL RESULT WAS 20.7 NG/L. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 5.5 NG/L AND 4.1 NG/L. ON (B)(6) 2025, PATIENT 10 INITIAL RESULT WAS 9.4 NG/L. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 6.2 NG/L AND 6.2 NG/L. ON (B)(6) 2025, PATIENT 11 INITIAL RESULT WAS 31.2 NG/L. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 24.8 NG/L AND 24.5 NG/L. ON (B)(6) 2025 PATIENT 12 INITIAL RESULT WAS 100 NG/L. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 84.4 NG/L AND 82.9 NG/L. ON (B)(6) 2025 PATIENT 13 INITIAL RESULT WAS 10.8 NG/L. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 5.6 NG/L AND 6.0 NG/L. ON (B)(6) 2025 PATIENT 14 INITIAL RESULT WAS 109 NG/L. THE REPEAT RESULT WAS 132 NG/L. THE SAMPLE WAS RECENTRIFUGED AND REPEATED WITH RESULTS OF 117 NG/L AND 113 NG/L. SECTION B7 WAS UPDATED.

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC WERE ACCEPTABLE. SAMPLE QUALITY-RELATED ALARMS WERE OBSERVED ON THE ALARM TRACE DATA. THE CUSTOMER USED A CENTRIFUGATION TIME OF 11 MINUTES AT 3403 REVOLUTIONS PER MINUTE (RPM). BASED ON THE CUSTOMER'S SAMPLE TUBES, THE CENTRIFUGATION CONDITIONS RECOMMENDED ARE 1300-2000 G FOR 10 MINUTES OR 3000 G FOR 5 MINUTES. THE SAMPLE FOAM DETECTION (SFD) IMAGES SHOWED MANY SAMPLES WITH PARTICLES. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. A GENERAL REAGENT OR INSTRUMENT ISSUE WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF DISCREPANT HIGH RESULTS FOR 3 PATIENT SAMPLES TESTED FOR ELECSYS TROPONIN T HS (TROPONIN T HS) ON COBAS E 801 ANALYTICAL UNIT. PATIENT 1 INITIAL RESULT WAS 66 PG/ML. THE REPEAT RESULT WAS 116 PG/ML. THE SAMPLE WAS REPEATED ON A DIFFERENT E801 ANALYZER WITH RESULTS OF 67 PG/ML. ON (B)(6) 2025, PATIENT 2 INITIAL RESULT WAS 85.9 PG/ML. THE REPEAT RESULT WAS 3.13 PG/ML WITH A DATA ALARM. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF < 3 PG/ML. PATIENT 3 INITIAL RESULT WAS 25.7 PG/ML. THE REPEAT RESULT WAS 19.6 PG/ML. THE SAMPLE WAS CENTRIFUGED AND RUN A DIFFERENT E801 ANALYZER WITH A RESULT OF 18.6 PG/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152577 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 811848

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown